Acute Stress DisorderNCT06502106
Internet-delivered Trauma-focused Cognitive-behavioral Therapy as an Early Intervention After Sexual Trauma
A study testing Condensed Internet delivered prolonged exposure (CIPE) in people with Acute Stress Disorder and Post Traumatic Stress Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The research aims to assess the practicality and implementation aspects, effectiveness, and processes of change related to Condensed Internet-delivered Prolonged Exposure (CIPE) administered as an early trauma focused intervention after sexual assault. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stress Disorder, Post Traumatic Stress Disorder
- What is being tested?
- Condensed Internet delivered prolonged exposure (CIPE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2024to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experienced trauma in the past two months according to criterion A for PTSD in the DSM-5 (exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence).
- At least mild clinical symptoms assessed using the PCL-5 cut-off >10
- ≥ 18 years
- Signed informed consent
Who cannot join
- Other serious comorbidity as primary concern (ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, borderline personality disorder, high suicidal risk)
- Unable to read and write in Swedish
- Receiving other psychological trauma-focused treatment
- Ongoing trauma-related threat (e.g., living with a violent spouse)
- Not stable dose of antidepressant medication the last two weeks
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Traumamottagning Centrum för Sexuell Hälsa, Skånes Universitetssjukhus
Malmö
Erik Wallmark, MSc, +46(0)40-33 34 46, erik.wallmark@skane.se
About this study
The research aims to assess the practicality and implementation aspects, effectiveness, and processes of change related to Condensed Internet-delivered Prolonged Exposure (CIPE) administered as an early trauma focused intervention after sexual assault. Eligible participants are individuals seeking help at Traumamottagning Centrum för Sexuell Hälsa, Malmö who have been exposed to sexual assualt in the past two months and exhibit psychological symptoms in response to that.
Read the detailed description
The study is un-controlled with 30 participants that will undergo a brief trauma-focused Internet-based CBT treatment, delivered as a three-week treatment comprising of four modules (psychoeducation/rational, in vivo exposure, imaginal exposure and relapse prevention). The primary outcome is level of symptoms of post traumatic stress rated by the PCL-5. Secondary outcomes are level of symptoms of post traumatic stress using the Clinician Administered PTSD Scale version 5 (CAPS-5) and The International Trauma Questionnaire (ITQ), level of depression (PHQ-9), quality of life (WSAS and EQ-5D ) dropout rate, rates of inclusion, attrition, adherence,and negative effects.
Qualitative data using a semi-structured interview will be gathered from participants at the end of the treatment collecting data on participants' views on the treatment, preferences for this type of treatment and how to further improve it.
The treatment effects will be evaluated using a within-group design with repeated measurements. Participants in the study will be will recruited from patients treated for sexual assault at Traumamottagning Centrum för Sexuell Hälsa, Malmö.
- Being tested
- Condensed Internet delivered prolonged exposure (CIPE)
- Keywords
- condensed prolonged exposure, PTSD, internetdelivered, trauma, early intervention, prevention, CIPE
- Medical subject headings
- Stress Disorders, Traumatic, Acute, Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Condensed Internet delivered prolonged exposure (CIPE)Behavioural
Condensed Internet delivered prolonged exposure (CIPE) with therapist support for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Condensed Internet delivered prolonged exposure (CIPE) | Experimental | Condensed Internet delivered prolonged exposure (CIPE) for three weeks with therapist support. Receives: Behavioral: Condensed Internet delivered prolonged exposure (CIPE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report measure based upon the Diagnostic and Statistical Manual (DSM-5) criteria for PTSD. Total Score (Range 0-80 with higher scores representing more PTSD symptoms.
Measured: Baseline, weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Secondary outcomes (7)
Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a widely used and well-validated instrument for measuring the severity of depressive symptoms. Scores are calculated based on how frequently a person experiences 9 symptoms of depression ranging from "not at all" response is scored as 0; "several days" response is 1; "more than half the days" response is 2; and "nearly every day" response is 3. Higher scores represents more depressive symptoms.
Measured: Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Clinician Administered PTSD Scale version 5 (CAPS-5), the gold standard clinical interview to assess PTSD symptom severity and diagnosis of PTSD
The CAPS-5 is a 20-item clinical administered interview based upon the Diagnostic and Statistical Manual (DSM-5) criteria for PTSD. Total Score (Range 0-80 with higher scores representing more PTSD symptoms.
Measured: Three months after treatment completion.
The International Trauma Questionnaire (ITQ)
The ITQ includes six items measuring each PTSD symptom cluster and these items measure how bothersome each symptom has been in the past month. The ITQ also includes six items measuring each 'Disturbance in Self- Organization' (DSO) symptom in complex PTSD. These items measure how a respondent typically feels, thinks about oneself, and relates to others. The PTSD and DSO symptoms are accompanied by three items measuring associated functional impairments in the domains of social, occupation, and other important areas of life. All items are answered on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Extremely). Thus, PTSD and DSO symptom scores range from 0 to 24 and CPTSD symptom scores range from 0 to 48. Higher scores represents more PTSD and complex PTSD symptoms.
Measured: Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Change in psychosocial impairment measured by The Work and Social Adjustment Scale (WSAS), adapted to symptoms of post-traumatic stress.
WSAS is a short, self-reported instrument consisting of five items about psychosocial impairments rated on a nine-point Likert scale. A higher score means more severe impairment.
Measured: Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Change in quality of life measured by EQ-5D
Change in overall health from baseline to post treatment and follow up . EQ-5D is a standardized self-report measure of overall health status measured in terms of five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using a three-level scale: 1 having no problems, 2 having some problems and 3 having extreme problems. A higher score indicate worse severity.
Measured: Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Change in use of alcohol measured by Alcohol Use Disorders Identification Test (AUDIT)
point Likert scale (0-4) and differentiates between hazardous alcohol use, dependence symptoms, and harmful alcohol use. The total score of the AUDIT ranges from 0 to 40 points, with a higher score reflecting greater risk of alcohol use disorders.
Measured: Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Change in drug use measured by Drug Use Disorders Identification Test (DUDIT)
Self-rated questionnaire on drug use. It contains 11 items that are scored on a five-point Likert scale (0-4) and differentiates between hazardous drug use, dependence symptoms, and harmful drug use. The total score of the DUDIT ranges from 0 to 44 points, with a higher score reflecting greater risk of drug use disorders.
Measured: Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Stress DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prolonged exposure will be offered in a brief digital format with therapist support for three weeks. Treatment comprises of psychoeducation, rationales, in vivo exposure, imaginal exposure and relapse prevention.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Traumamottagning Centrum för Sexuell Hälsa, Skånes Universitetssjukhus, Malmö
- Responsible party
- Principal investigator, Maria Bragesjo, Karolinska Institutet
- Investigators
- Maria Bragesjö, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502106
- Sponsor's protocol ID
- 2024-01105-01
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Trauma-focused Cognitive-behavioral Therapy as an Early Intervention After Sexual Trauma
- ClinicalTrials.gov ID
- NCT06502106
- Acronym / sponsor ID
- 2024-01105-01
- Keywords
- condensed prolonged exposure, PTSD, internetdelivered, trauma, early intervention, prevention, CIPE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Traumamottagning Centrum för Sexuell Hälsa, Skånes Universitetssjukhus, Malmö
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research aims to assess the practicality and implementation aspects, effectiveness, and processes of change related to Condensed Internet-delivered Prolonged Exposure (CIPE) administered as an early trauma focused intervention after sexual assault. Eligible participants are individuals seeking help at Traumamottagning Centrum för Sexuell Hälsa, Malmö who have been exposed to sexual assualt in the past two months and exhibit psychological symptoms in response to that.
Detailed description
The study is un-controlled with 30 participants that will undergo a brief trauma-focused Internet-based CBT treatment, delivered as a three-week treatment comprising of four modules (psychoeducation/rational, in vivo exposure, imaginal exposure and relapse prevention). The primary outcome is level of symptoms of post traumatic stress rated by the PCL-5. Secondary outcomes are level of symptoms of post traumatic stress using the Clinician Administered PTSD Scale version 5 (CAPS-5) and The International Trauma Questionnaire (ITQ), level of depression (PHQ-9), quality of life (WSAS and EQ-5D ) dropout rate, rates of inclusion, attrition, adherence,and negative effects.
Qualitative data using a semi-structured interview will be gathered from participants at the end of the treatment collecting data on participants' views on the treatment, preferences for this type of treatment and how to further improve it.
The treatment effects will be evaluated using a within-group design with repeated measurements. Participants in the study will be will recruited from patients treated for sexual assault at Traumamottagning Centrum för Sexuell Hälsa, Malmö.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prolonged exposure will be offered in a brief digital format with therapist support for three weeks. Treatment comprises of psychoeducation, rationales, in vivo exposure, imaginal exposure and relapse prevention.
| Arm | Type | Receives |
|---|---|---|
| Condensed Internet delivered prolonged exposure (CIPE) | Experimental | Behavioral: Condensed Internet delivered prolonged exposure (CIPE)Condensed Internet delivered prolonged exposure (CIPE) for three weeks with therapist support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Experienced trauma in the past two months according to criterion A for PTSD in the DSM-5 (exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence).
- At least mild clinical symptoms assessed using the PCL-5 cut-off >10
- ≥ 18 years
- Signed informed consent
Key exclusion criteria (5 listed)
- Other serious comorbidity as primary concern (ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, borderline personality disorder, high suicidal risk)
- Unable to read and write in Swedish
- Receiving other psychological trauma-focused treatment
- Ongoing trauma-related threat (e.g., living with a violent spouse)
- Not stable dose of antidepressant medication the last two weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Condensed Internet delivered prolonged exposure (CIPE)Condensed Internet delivered prolonged exposure (CIPE) with therapist support for three weeks. | Behavioural | Condensed Internet delivered prolonged exposure (CIPE) |
Primary outcome
Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
Time frame: Baseline, weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
The PCL-5 is a 20-item self-report measure based upon the Diagnostic and Statistical Manual (DSM-5) criteria for PTSD. Total Score (Range 0-80 with higher scores representing more PTSD symptoms.
7 secondary outcomes
Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Clinician Administered PTSD Scale version 5 (CAPS-5), the gold standard clinical interview to assess PTSD symptom severity and diagnosis of PTSD
Time frame: Three months after treatment completion.
The International Trauma Questionnaire (ITQ)
Time frame: Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Change in psychosocial impairment measured by The Work and Social Adjustment Scale (WSAS), adapted to symptoms of post-traumatic stress.
Time frame: Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Change in quality of life measured by EQ-5D
Time frame: Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Change in use of alcohol measured by Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Change in drug use measured by Drug Use Disorders Identification Test (DUDIT)
Time frame: Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Bragesjö, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Condensed Internet delivered prolonged exposure (CIPE) in people with Acute Stress Disorder and Post Traumatic Stress Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Bragesjö, PhD (+46703399387, maria.bragesjo@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5) (time frame: Baseline, weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.